D1.448 - Long-Term Efficacy and Stability of Lebrikizumab in Treating Face/Head and Neck Involvement in Patients with Moderate-to-Severe Atopic Dermatitis

Lebrikizumab (LEB), a high-affinity IL-13 inhibitor, has shown long-term efficacy and stability of response for up to 3 years as monotherapy treatment for moderate-to-severe atopic dermatitis (AD). Notably, head and neck (HN) involvement represents a particularly burdensome manifestation of AD, with a disproportionate negative impact on quality of life compared with AD affecting other body regions. We evaluated the long-term efficacy and stability of LEB treatment response in the HN region over 3 years in participants with moderate-to-severe AD.

In ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), adults and adolescents were randomized 2:1 to receive LEB 250 mg Q2W monotherapy, with a 500 mg loading dose at baseline and W2, or placebo (PBO). After W16, individuals receiving LEBQ2W who met protocol-defined response criteria were randomized 2:2:1 to receive LEBQ2W, LEBQ4W, or PBO (LEB withdrawal). Those treated with LEB who completed W52 of ADvocate1 & 2 could enroll in the ADjoin (NCT04392154) LTE and received the same treatment regimen as in the ADvocate1 & 2 maintenance period. Long-term head and neck Eczema Area and Severity Index component (HN-EASI) response rates were reported as observed, using all collected data regardless of rescue medication use for the W16 LEB per protocol responders who achieved the corresponding HN-EASI response. Further stability analyses determined the LEB-treated W16 HN-EASI 75, 90, and 100 responders who maintained HN-EASI 75, HN-EASI 90, and HN-EASI 100, at individual level, in ≥80% of attended visits from W16-W152, respectively.

Among those who achieved the corresponding HN-EASI at W16 of ADvocate1 & 2, 82.7% and 94.8% maintained HN-EASI 75, 81.8% and 82.9% maintained HN-EASI 90, 88.5% and 85.3% maintained HN-EASI 100 at W152 in the LEBQ2W and LEBQ4W arms, respectively. A stable HN-EASI 75, HN-EASI 90, and HN-EASI 100 response from W16-W152 was achieved in 81.2%, 82.2%, and 86.1% of LEBQ2W participants, and in 88.8%, 80.0%, and 74.0% of LEBQ4W participants, respectively.

Most individuals maintained clear or almost clear skin in the HN region over 152W of continuous LEB treatment in both LEB arms. Moreover, LEB demonstrates long-term stability of HN response with no or minimal fluctuations measured by HN-EASI 75, HN-EASI 90, and HN-EASI 100. LEB is an effective and broadly applicable treatment option for all patients with moderate-to-severe AD, including those with HN involvement.